Soliris

"The Centers for Disease Control and Prevention has identified a cluster of newborns in Tennessee with late vitamin K deficiency bleeding (VKDB). VKDB is a serious, but preventable bleeding disorder that can cause bleeding in the brain. In each"...

Gently invert the infusion bag containing the diluted
Soliris solution to ensure thorough mixing of the product and diluent. Discard
any unused portion left in a vial, as the product contains no preservatives. Prior
to administration, the admixture should be allowed to adjust to room
temperature [18°-25° C, 64-77° F]. The admixture must not be heated in a
microwave or with any heat source other than ambient air temperature. The
Soliris admixture should be inspected visually for particulate matter and
discoloration prior to administration.

Administration

Do not administer as an intravenous push or bolus injection.

The Soliris admixture should be administered by
intravenous infusion over 35 minutes in adults and 1 to 4 hours in pediatric
patients via gravity feed, a syringe-type pump, or an infusion pump. Admixed
solutions of Soliris are stable for 24 hours at 2-8° C (36-46° F) and at room
temperature.

If an adverse reaction occurs during the administration
of Soliris, the infusion may be slowed or stopped at the discretion of the
physician. If the infusion is slowed, the total infusion time should not exceed
two hours in adults. Monitor the patient for at least one hour following
completion of the infusion for signs or symptoms of an infusion reaction.

Storage And Handling

Soliris Vials must be stored in the original carton until
time of use under refrigerated conditions at 2-8°C (36-46°F) and protected from
light. Do not use beyond the expiration date stamped on the carton. Refer to
[Dosage and Administration] for information on the stability and storage of
diluted solutions of Soliris